Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5102
Study information
Scientific title
Randomised comparison of three weight control programmes during adjuvant treatment for early breast cancer (Breast - Activity and Healthy Eating After Diagnosis)
Acronym
B- AHEAD
Study hypothesis
To determine whether individualised weight control programmes are better than standard written advice for existing weight and preventing weight gain in first year after breast cancer treatment for women with early breast cancer.
On 06/05/2015 the overall trial end date was changed from 01/12/2010 to 02/02/2012.
Ethics approval
First MREC approval date 09/07/2008 (ref: 08/H1013/45)
Study design
Randomised interventional multicentre process of care trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Intervention
Current interventions as of 30/04/2015:
Group 1 (Control): Standard written advice
This group will receive standard written diet and exercise advice.
Group 2 (Intervention): Individualised home-based intervention
Each woman receives individualised diet and exercise advice from the study dietitian (40 minutes) and exercise referral officer (40 minutes). This advice will be reinforced with bi-weekly phone calls (study dietitian) and mailed information during the first 12 weeks, and booster phone calls during the 12-month study.
Group 3 (Intervention): Supervised group community-based weight control programme
Each woman received individualised diet and exercise advice from the study dietitian (40 minutes) and exercise referral officer (40 minutes). They are then asked to attend weekly group classes for the first 12 weeks which comprise an exercise class followed by a diet and behaviour change educational component with handouts, and booster phone calls during the 12-month study.
Previous interventions:
Group 1 (Control): Standard written advice -
This group will receive standard written diet and exercise advice.
Group 2 (Intervention): Individualised home based intervention:
Each woman receives individualised diet and exercise advice from the study dietitian (40 minutes) and exercise referral officer (40 minutes). This advice will be reinforced with bi-weekly phone calls (study dietitian) and mailed information during the first 12 weeks, and booster phone calls during the 12-month study.
Follow Up Length: 12 month(s)
Study Entry: Single Randomisation only
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measures
Changes in body weight and composition (body fat, fat free mass DXA, bioelectrical impedance)
Secondary outcome measures
Uptake and retention to the programmes and any adverse effects of the programmes.
Overall trial start date
11/08/2008
Overall trial end date
02/02/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Within 10 weeks of primary surgery for primary breast cancer (invasive or in-situ)
2. Pre and postmenopausal women of any age able to undertake interventions
3. Any weight, as programmes aim to tackle existing weight problems and prevent weight gain in healthy weight women
4. Receiving/due to start adjuvant chemotherapy, radiotherapy or endocrine therapy or no adjuvant treatment
5. Early breast cancer stages I - III
6. Ability to understand written instructions and have completed baseline 7 day diet and exercise diaries
7. Resident within Greater Manchester only in order to maximise uptake and retention to interventions and study
8. Written informed consent
9. Females, no specified age limit
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 480; UK Sample Size: 480
Participant exclusion criteria
1. Metastatic or inoperable disease
2. Physical/psychiatric condition which impairs compliance or mobility assessed from medical history by recruitment nurse or verified from baseline fitness assessment by the trial physiotherapist, i.e.:
2.1. Insulin requiring diabetes, as diet and physical activity changes would require close coordination with the treating physician. Non-insulin requiring diabetics are eligible for the study.
2.2. Serious digestive and/or absorptive problems, including inflammatory bowel disease
2.3. Cardiovascular, respiratory (determined from recent pre-operative electrocardiogram [ECG], chest X-ray) disease
2.4. Musculoskeletal disease or joint problems
2.5. Psychiatric disorders or conditions, e.g., untreated major depression, psychosis, substance abuse, severe personality disorder
3. Women who regularly take daily medication known to effect body composition, e.g., corticosteroids (women receiving 2 - 3 days steroids with chemotherapy may be included)
4. Patients with metal implants, ie hip prosthesis are excluded from the study as this precludes DXA measurement of body fat (breast implants, pacemakers are not excluded)
5. Women who have received neoadjuvant chemotherapy or endocrine
6. Patients considering reconstruction surgery in the next 12 months
Recruitment start date
11/08/2008
Recruitment end date
02/02/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital of South Manchester NHS Foundation Trust
M23 9LT
United Kingdom
Trial participating centre
The Christie Hospital NHS Trust
M20 4BX
United Kingdom
Trial participating centre
Mid Cheshire NHS Foundation Trust
CW1 4QJ
United Kingdom
Trial participating centre
East Cheshire NHS Trust
SK10 3BL
United Kingdom
Trial participating centre
Pennine Acute Hospitals NHS Trust
M8 5RB
United Kingdom
Trial participating centre
Salford Royal NHS Foundation Trust
M6 8HD
United Kingdom
Trial participating centre
Stockport NHS Foundation Trust
SK2 7JE
United Kingdom
Trial participating centre
Tameside Hospital NHS Foundation Trust
OL6 9RW
United Kingdom
Sponsor information
Organisation
South Manchester University Hospital (UK)
Sponsor details
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary